Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection

Masimo

Status

Terminated

Conditions

Healthy

Treatments

Device: INVSENSOR00057

Study type

Interventional

Funder types

Industry

Identifiers

NCT05476250

CIP-1022

Details and patient eligibility

About

This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The subject is 18 to 80 years of age.
Subject can read and communicate in English.
Subject's cardiac rhythm shall be Normal Sinus Rhythm or Atrial Fibrillation (Afib). This determination will be made using FDA cleared 3-lead ECG which will label subject's cardiac rhythm as such.

Exclusion criteria

Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.